NPI Manager - #1116931

Menicon is a contact lens specialist embracing precision craftsmanship to see life in detail. Join our family in Singapore, the first manufacturing facility outside Japan for daily disposable contact lens and a base for developing technologies and products with advanced, value-added features.

Reporting to the Senior Manager for Operations, the NPI Manager leads a team of engineers in process development, product improvements, validation and will be the key liaison with Japan headquarters on new product development.

Responsibilities:

• Lead initiatives to enhance product performance, manufacturability and cost effectiveness

• Identify and implement process improvements to increase yield, reduce variation, and ensure consistent quality in manufacturing.

• Oversees validation for processes and products, including OQ/PQ

• Lead validation efforts for software and digitized processes, including ERP system, electronic records etc

• Ensure compliance to ISO13485, FDA and other regulatory requirements (eg: FDA 21 CFR Part 11)

• Manage end to end new product development projects from feasibility through launch

• Facilitate and ensure alignment across global teams eg: R&D, Marketing, Regulatory, Quality, Supply Chain

• Lead and ensure robust design control documentation

Requirements:

• Degree in Engineering, Material Science, Biomedical Engineering or related discipline.

• 8 years working experience in a pharmaceutical or medical device industry.

• Experience in manufacturing process development, validation

• Knowledge of ISO13485

• Strong leadership skills, with the ability to influence and drive results in cross-functional and global teams.

• Strong Project Management skills